Profile Details

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★★★★★

☆☆☆☆☆

USD 165 /hr

★★★★★

☆☆☆☆☆

Hire Eddie W.

Switzerland

USD 165 /hr

10 year ex-Abbott RA/QA professional | Expert in ISO 13485, CE Marking, 510(k) and WHO PQ for MD and IVDs

Profile Summary

I'm excited to help businesses reach market approval on their new or existing medical devices and IVDs. I have experience working with both small/medium enterprises as a supplier auditor, establishing ISO 13485 QMS in 500+ large organizations, and bringing devices to market at record speed.

Subject Matter Expertise

• ☆ Medical Devices
• ☆ Medical Device Development
• ☆ Medical Device Manufacturing
• ☆ Medical Device Design
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ In vitro Diagnostics
• ☆ In vitro Diagnostic Validation
• ☆ In vitro Diagnostic Design
• ☆ Point-of-Care Devices
• ☆ Medical Equipment & Supplies

Services

• Writing

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing

Work Experience

Sr. Manager Regulatory Affairs

Abbott Laboratories

January 2015 - July 2025

Education

Masters in Public Health

Emory University

September 2012 - May 2014

Bachelors

Johns Hopkins University

September 2009 - May 2012

Certifications

• ISO 13485 lead auditor

  bsi

  February 2016 - Present